Sotyktu
deucravacitinib
Table of contents
Overview
Sotyktu is a medicine for treating adults with moderate to severe plaque psoriasis (an inflammatory disease causing red, scaly patches on the skin) who are eligible for systemic therapy (treatment with a medicine given by mouth or by injection).
Sotyktu contains the active substance deucravacitinib.
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List item
Sotyktu : EPAR - Medicine overview (PDF/122.19 KB)
Adopted
First published: 31/03/2023
EMA/109564/2023 -
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List item
Sotyktu : EPAR - Risk Management Plan (PDF/4.95 MB)
First published: 31/03/2023
Authorisation details
Product details | |
---|---|
Name |
Sotyktu
|
Agency product number |
EMEA/H/C/005755
|
Active substance |
Deucravacitinib
|
International non-proprietary name (INN) or common name |
deucravacitinib
|
Therapeutic area (MeSH) |
Psoriasis
|
Anatomical therapeutic chemical (ATC) code |
L04AA
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Publication details | |
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Marketing-authorisation holder |
Bristol-Myers Squibb Pharma EEIG
|
Date of issue of marketing authorisation valid throughout the European Union |
24/03/2023
|
Contact address |
Plaza 254 |
Product information
24/03/2023 Sotyktu - EMEA/H/C/005755 -
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Immunosuppressants
Therapeutic indication
Treatment of moderate-to-severe plaque psoriasis in adults.